GAK — Suture, Absorbable Class II
FDA product code GAK covers "Suture, Absorbable", a Class II medical device regulated under 21 CFR 878.4830. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GAK
- Device Class
- Class II
- Regulation Number
- 878.4830
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914365 | davis and geck | DEXON DISSECTING SPONGE | October 23, 1991 |